TPLC - Total Product Life Cycle

show TPLC since

Device	folders and injectors, intraocular lens (iol)
Regulation Description	Intraocular lens guide.
Product Code	MSS
Regulation Number	886.4300
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Damaged by Another Device	669	670
Device Contamination with Chemical or Other Material	338	338
Adverse Event Without Identified Device or Use Problem	210	210
Crack	145	145
Scratched Material	115	116
Material Split, Cut or Torn	95	95
Material Twisted/Bent	77	77
Failure to Eject	76	76
Defective Device	74	74
Break	72	75
Defective Component	60	60
Difficult to Advance	43	43
Insufficient Information	33	33
Inaccurate Delivery	21	23
No Apparent Adverse Event	20	23
Physical Resistance/Sticking	19	19
Failure to Advance	18	18
Contamination	18	21
Particulates	18	18
Priming Problem	16	16
Device Difficult to Setup or Prepare	15	15
Appropriate Term/Code Not Available	13	13
Difficult to Insert	9	9
Material Deformation	8	8
Failure to Deliver	7	7
Ejection Problem	6	6
Unintended Ejection	6	6
Use of Device Problem	6	6
Contamination /Decontamination Problem	5	5
Mechanical Jam	4	6
Product Quality Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Off-Label Use	3	3
Material Fragmentation	3	5
Material Rupture	3	3
Failure to Fold	2	2
Mechanical Problem	2	2
Activation, Positioning or Separation Problem	2	2
Fitting Problem	2	2
Structural Problem	1	1
No Pressure	1	1
Packaging Problem	1	1
Stretched	1	1
Patient Device Interaction Problem	1	1
Material Separation	1	1
Malposition of Device	1	1
Device Dislodged or Dislocated	1	1
Operating System Becomes Nonfunctional	1	1
Unstable	1	1
Premature Discharge of Battery	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	970	980
Insufficient Information	792	792
Capsular Bag Tear	45	45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	40
Eye Injury	25	25
Corneal Edema	21	21
Visual Impairment	21	21
Toxic Anterior Segment Syndrome (TASS)	16	16
Endophthalmitis	12	12
Inflammation	10	10
No Code Available	9	9
Eye Pain	8	8
Blurred Vision	8	8
Visual Disturbances	7	7
Foreign Body Sensation in Eye	6	6
Vitreous Loss	6	6
Loss of Vision	5	5
Foreign Body In Patient	5	5
Hypopyon	5	5
Keratitis	4	4
Red Eye(s)	4	4
Swelling/ Edema	4	4
Vitreous Floaters	4	4
Iritis	4	4
Uveitis	4	4
Unspecified Eye / Vision Problem	3	3
Failure of Implant	3	3
Intraocular Pressure Increased	3	3
Fibrosis	3	3
Wound Dehiscence	3	3
Zonular Dehiscence	2	2
Conjunctivitis	2	2
Corneal Abrasion	2	2
Prolapse	2	2
Capsular Contracture	2	2
Vitrectomy	2	2
Edema	1	1
Ventricular Tachycardia	1	1
Corneal Touch	1	1
Corneal Decompensation	1	1
Discomfort	1	1
Unspecified Tissue Injury	1	1
Hyphema	1	1
Bacterial Infection	1	1
No Consequences Or Impact To Patient	1	1
Corneal Scar	1	1